RECRUITINGINTERVENTIONAL
Small Extracellular Vesicles and Insulin Action
Effect of Small Extracellular Vesicles From Adipose Tissue on Insulin Action
About This Trial
The goals of this research study are to: 1) understand why some people with obesity are protected from developing conditions such as type 2 diabetes and cardiovascular disease while others are more likely to develop obesity-related conditions; 2) assess the effect of small extracellular vesicles (sEVs also called exosomes), obtained from human participants, on metabolic function in cultured cells and in mice.
Who May Be Eligible (Plain English)
Who May Qualify:
- Metabolically healthy lean subjects must have a BMI ≥18.5 and ≤24.9 kg/m²; Subjects with obesity must have a BMI ≥30.0 and ≤50.0 kg/m²
- Metabolically healthy lean and people with metabolically healthy obesity must have intrahepatic triglyceride (IHTG) content ≤5%; fasting plasma glucose concentration \<100 mg/dl, 2-hr oral glucose tolerance plasma glucose concentration \<140 mg/dl, hemoglobin A 1C (HbA1c) ≤5.6% and HOMA-IR \<2.5.
- People with metabolically unhealthy obesity must have intrahepatic triglyceride (IHTG) content ≥5.6%; HOMA-IR ≥2.5, and HbA1c 5.7%-6.4%, or fasting plasma glucose concentration ≥100 mg/dl, or 2-hr oral glucose tolerance test (OGTT) plasma glucose concentration ≥140 mg/dl.
Who Should NOT Join This Trial:
- History of diabetes, liver disease other than NAFLD or other serious diseases,
- Consume excessive amounts of alcohol (\>21 units/week for men and \>14 units/week for women),
- Take medications that could affect the study outcome measures, engage in regular exercise (\>120 min/week),
- Are pregnant or lactating
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Metabolically healthy lean subjects must have a BMI ≥18.5 and ≤24.9 kg/m²; Subjects with obesity must have a BMI ≥30.0 and ≤50.0 kg/m²
* Metabolically healthy lean and people with metabolically healthy obesity must have intrahepatic triglyceride (IHTG) content ≤5%; fasting plasma glucose concentration \<100 mg/dl, 2-hr oral glucose tolerance plasma glucose concentration \<140 mg/dl, hemoglobin A 1C (HbA1c) ≤5.6% and HOMA-IR \<2.5.
* People with metabolically unhealthy obesity must have intrahepatic triglyceride (IHTG) content ≥5.6%; HOMA-IR ≥2.5, and HbA1c 5.7%-6.4%, or fasting plasma glucose concentration ≥100 mg/dl, or 2-hr oral glucose tolerance test (OGTT) plasma glucose concentration ≥140 mg/dl.
Exclusion Criteria:
* History of diabetes, liver disease other than NAFLD or other serious diseases,
* Consume excessive amounts of alcohol (\>21 units/week for men and \>14 units/week for women),
* Take medications that could affect the study outcome measures, engage in regular exercise (\>120 min/week),
* Are pregnant or lactating
Treatments Being Tested
BEHAVIORAL
People with Metabolically Unhealthy Obesity - Low Calorie Diet
Consumption of a low-calorie diet with caloric intake reduced by \~25% to achieve \~10% weight loss in about 4 to 5 months.
Locations (1)
Washington University School of Medicine
St Louis, Missouri, United States